Graphical symbols for use in the labelling of medical devices

This European Standard specifies graphical symbols for use in the information supplied by the manufacturer with medical devices.  Note: This standard does not specify the circumstances under which particular symbols are used. Guidance on this is given in prEN 1041.

Graphische Symbole zur Kennzeichnung von Medizinprodukten

Diese europäische Norm legt die graphischen Symbole fest, die von den Herstellern für Informationen zu Medizinprodukten, wie sie in den EG-Richtlinien über Medizinprodukte, aktive implantierbare Medizinprodukte und In-vitro-Diagnostika (in Vorbereitung) definiert sind, verwendet werden sollten.

Symboles graphiques utilisés pour l'étiquetage des dispositifs médicaux

La présente norme européenne spécifie les symboles graphiques destinés à être inclus dans les informations fournies par le fabricant avec les dispositifs médicaux, tels que définis dans les Directives de la CEE relatives aux dispositifs médicaux, aux dispositifs médicaux implantables actifs et aux dispositifs médicaux de diagnostic in vitro (en cours d'élaboration).

Grafični simboli za označevanje medicinskih pripomočkov

General Information

Status
Withdrawn
Publication Date
21-May-1996
Withdrawal Date
15-Apr-2003
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
16-Apr-2003
Completion Date
16-Apr-2003

Relations

Effective Date
22-Dec-2008
Effective Date
10-Feb-2026
Effective Date
28-Jan-2026
Effective Date
22-Dec-2008
Effective Date
22-Dec-2008

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Frequently Asked Questions

EN 980:1996 is a standard published by the European Committee for Standardization (CEN). Its full title is "Graphical symbols for use in the labelling of medical devices". This standard covers: This European Standard specifies graphical symbols for use in the information supplied by the manufacturer with medical devices. Note: This standard does not specify the circumstances under which particular symbols are used. Guidance on this is given in prEN 1041.

This European Standard specifies graphical symbols for use in the information supplied by the manufacturer with medical devices. Note: This standard does not specify the circumstances under which particular symbols are used. Guidance on this is given in prEN 1041.

EN 980:1996 is classified under the following ICS (International Classification for Standards) categories: 01.080.20 - Graphical symbols for use on specific equipment; 11.040.01 - Medical equipment in general; 11.120.01 - Pharmaceutics in general. The ICS classification helps identify the subject area and facilitates finding related standards.

EN 980:1996 has the following relationships with other standards: It is inter standard links to EN 980:2003, EN 45502-1:1997, EN 12838:2000, EN 980:1996/A1:1999, EN 980:1996/A2:2001. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN 980:1996 is associated with the following European legislation: EU Directives/Regulations: 90/385/EEC, 93/42/EEC, 98/79/EC; Standardization Mandates: M/252, M/BC/CEN/89/9. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

EN 980:1996 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)


SLOVENSKI STANDARD
01-januar-2000
*UDILþQLVLPEROL]DR]QDþHYDQMHPHGLFLQVNLKSULSRPRþNRY
Graphical symbols for use in the labelling of medical devices
Graphische Symbole zur Kennzeichnung von Medizinprodukten
Symboles graphiques utilisés pour l'étiquetage des dispositifs médicaux
Ta slovenski standard je istoveten z: EN 980:1996
ICS:
01.080.20 *UDILþQLVLPEROL]DSRVHEQR Graphical symbols for use on
RSUHPR specific equipment
11.040.01 Medicinska oprema na Medical equipment in general
splošno
11.120.01 Farmacija na splošno Pharmaceutics in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

SIST EN
...

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